Product information

From Health Canada

The product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. The veterinary labelling is developed by the drug sponsor according to the Food and Drug Regulations. While Health Canada reviews the product monograph or the veterinary labelling as part of the drug review process, it remains the responsibility of the drug sponsor to ensure that the product monograph or the veterinary labelling is complete and accurate.

Current status:

Marketed

Current status date:

2017-01-24

Original market date: See footnote 1

2017-01-24

Product name:

ODAN-FLUOXETINE

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DIN:

02459361

Product Monograph/Veterinary Labelling:

Date: 2023-02-08 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

ODAN LABORATORIES LTD
325 Stillview Avenue
Pointe-Claire
Quebec
Canada H9R 2Y6

Class:

Human

Dosage form(s):

Solution

Route(s) of administration:

Oral

Number of active ingredient(s):

1

Schedule(s):

Prescription

 

American Hospital Formulary Service (AHFS): See footnote 3

28:16.04.20 

Anatomical Therapeutic Chemical (ATC): See footnote 4

N06AB03 FLUOXETINE

Active ingredient group (AIG) number:See footnote5

0116847002

List of active ingredient(s)
Active ingredient(s) Strength
FLUOXETINE (FLUOXETINE HYDROCHLORIDE) 20 MG / 5 ML
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